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Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.

Arm/Group Title

Fluzone® Vaccine (Group 1)

Fluzone® Intradermal Vaccine (Group 2)

Fluzone® Vaccine (Group 3)

Fluzone® High-Dose Vaccine (Group 4)

Arm/Group Description:

Adults 18 to < 65 years of age rece...

Adults 18 to < 65 years of age rece...

Adults ≥ 65 years of age received o...

Adults ≥ 65 years of age received o...

Arm/Group Description:

Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly

Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally

Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly

Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly

Overall Number of Participants Analyzed

50

50

51

49

Measure Type: Number

Unit of Measure: Participants

Injection site Pain

12

20

12

19

Grade 3 Injection site Pain

0

0

0

0

Injection site Erythema

1

16

0

1

Grade 3 Injection site Erythema

0

0

0

0

Injection site Swelling

1

9

0

1

Grade 3 Injection site Swelling

0

0

0

0

Injection site Induration

1

4

0

1

Grade 3Injection site Induration

0

0

0

0

Injection site Ecchymosis

0

1

0

0

Grade 3 Injection site Ecchymosis

0

0

0

0

Fever

2

0

0

0

Grade 3 Fever

0

0

0

0

Headache

10

12

11

7

Grade 3 Headache

1

1

0

0

Malaise

11

11

10

7

Grade 3 Malaise

0

0

0

0

Myalgia

10

10

13

7

Grade 3 Myalgia

0

0

2

0

Shivering

4

4

4

3

Grade 3 Shivering

0

0

0

0

2.Other Pre-specified Outcome

Title

Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine

Description

Anti-influenza antibodies were measured using a hemagglutination inhib...

Description

Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.

Time Frame

Day 0 (pre-vaccination) up to Day 21 post-vaccination

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Geometric mean titers against the influenza virus antigens were assessed in the Per-Protocol Analysis Set.

Arm/Group Title

Fluzone® Vaccine (Group 1)

Fluzone® Intradermal Vaccine (Group 2)

Fluzone® Vaccine (Group 3)

Fluzone® High-Dose Vaccine (Group 4)

Arm/Group Description:

Adults 18 to < 65 years of age rece...

Adults 18 to < 65 years of age rece...

Adults ≥ 65 years of age received o...

Adults ≥ 65 years of age received o...

Arm/Group Description:

Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly

Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally

Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly

Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly

Overall Number of Participants Analyzed

46

47

49

46

Geometric Mean (95% Confidence Interval)

Unit of Measure: Titers

A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46)

28.3

(17.5 to 45.6)

30.7

(18.3 to 51.7)

58.6

(37.5 to 91.6)

81.8

(50.2 to 133)

A/H1N1 (Post-vaccination; N = 46, 47, 49, 46)

1068

(755 to 1512)

1473

(955 to 2269)

246

(177 to 343)

369

(266 to 513)

A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46)

29.1

(18.0 to 47.3)

23.6

(14.3 to 39.0)

68.5

(42.6 to 110)

78.2

(50.2 to 122)

A/H3N2 (Post-vaccination; N = 45, 47, 49, 46)

460

(306 to 691)

599

(369 to 971)

264

(176 to 397)

392

(266 to 578)

B (Pre-vaccination; N = 46, 46, 49, 46)

17.9

(13.0 to 24.6)

20.9

(15.5 to 28.3)

13.7

(10.5 to 17.7)

18.7

(14.4 to 24.3)

B (Post-vaccination; N = 45, 47, 49, 46)

169

(131 to 218)

129

(91.1 to 183)

35.2

(25.8 to 48.1)

60.1

(43.8 to 82.4)

3.Other Pre-specified Outcome

Title

Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine

Description

Anti-influenza antibodies were measured using a hemagglutination inhib...

Description

Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil).

Time Frame

Day 0 (pre-vaccination) and Day 21 post-vaccination

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Seroprotection against influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.

Arm/Group Title

Fluzone® Vaccine (Group 1)

Fluzone® Intradermal Vaccine (Group 2)

Fluzone® Vaccine (Group 3)

Fluzone® High-Dose Vaccine (Group 4)

Arm/Group Description:

Adults 18 to < 65 years of age rece...

Adults 18 to < 65 years of age rece...

Adults ≥ 65 years of age received o...

Adults ≥ 65 years of age received o...

Arm/Group Description:

Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly

Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally

Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly

Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly

Overall Number of Participants Analyzed

46

47

49

46

Measure Type: Number

Unit of Measure: Participants

A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46)

22

23

32

33

A/H1N1 (Post-vaccination; N = 46, 47, 49, 46)

46

46

49

45

A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46)

22

15

33

31

A/H3N2 (Post-vaccination; N = 45, 47, 49, 46)

44

45

46

45

B (Pre-vaccination; N = 46, 46, 49, 46)

9

15

8

13

B (Post-vaccination; N = 45, 47, 49, 46)

45

40

26

33

4.Other Pre-specified Outcome

Title

Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine

Description

Anti-influenza antibodies were measured using a hemagglutination inhib...

Description

Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.

Time Frame

Day 0 (pre-vaccination) and Day 21 post-vaccination

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Seroconversion to the influenza virus vaccine antigens was assessed in the Per-Protocol Analysis Set.

Arm/Group Title

Fluzone® Vaccine (Group 1)

Fluzone® Intradermal Vaccine (Group 2)

Fluzone® Vaccine (Group 3)

Fluzone® High-Dose Vaccine (Group 4)

Arm/Group Description:

Adults 18 to < 65 years of age rece...

Adults 18 to < 65 years of age rece...

Adults ≥ 65 years of age received o...

Adults ≥ 65 years of age received o...

Arm/Group Description:

Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly

Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally

Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly

Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly

Overall Number of Participants Analyzed

46

47

49

46

Measure Type: Number

Unit of Measure: Participants

A/H1N1 (N = 46, 46, 49, 46)

43

43

21

26

A/H3N2 (N = 45, 46, 49, 46)

34

39

19

28

B (N = 45, 46, 49, 46)

36

33

13

16

5.Other Pre-specified Outcome

Title

Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine

Description

Anti-influenza antibodies were measured using a hemagglutination inhib...

Description

Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of <1:10.

Time Frame

Day 0 (pre-vaccination) and Day 21 post-vaccination

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Antibody responses to the influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.

Arm/Group Title

Fluzone® Vaccine (Group 1)

Fluzone® Intradermal Vaccine (Group 2)

Fluzone® Vaccine (Group 3)

Fluzone® High-Dose Vaccine (Group 4)

Arm/Group Description:

Adults 18 to < 65 years of age rece...

Adults 18 to < 65 years of age rece...

Adults ≥ 65 years of age received o...

Adults ≥ 65 years of age received o...

Arm/Group Description:

Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly

Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally

Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly

Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications